Home NDC 75907-043 Trimethoprim
Product NDC 75907-043
11-digit product format 759070043
Labeler code 75907
Product ID 75907-043_3523d9e9-608e-4a43-6a70-acb8c84aff7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trimethoprim
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Labratories Inc.
Application NDA018679
Marketing category NDA
Marketing start 2024-01-30
Substance TRIMETHOPRIM
Active strength 100 mg/1
Pharmacologic classes Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018679-001 TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018679-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Trimethoprim
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIMETHOPRIM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AN164J8Y0X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198332 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75907-043-01 Trimethoprim 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-043 TRIMETHOPRIM TABLET [DR. REDDY'S LABRATORIES INC.] 1 Current NDC, 1 package rows 20240130_73ccebc1-7412-2424-d62c-a5180ec52d81.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75907-043-01 75907004301 100 TABLET in 1 BOTTLE (75907-043-01) 100 tablet 2024-01-30 No No Current